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NCT03984825 · ClinicalTrials.gov registry record · Phase 1
Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT03984825 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 23 participants.
The verdict
NCT03984825, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodeficiency virus (HIV) is important in the prevention of unplanned pregnancies. The study will consist of a screening period of 28 days, check-in (Day -4), a run-in period and a treatment period. During the run-in period, subjects will be administered Portia® (0.03 milligrams \[mg\] EE/0.15 mg LNG) once daily on Days -3 to -1. Subjects will then be administered Portia once daily on Days 1 to 10 of treatment period A followed by administration of Portia once daily along with GSK3640254 200 mg on Days 11 to 21 of treatment period B. The duration of the study is approximately 8 weeks, including Screening and Run-in. Portia is a registered trademark of Teva Pharmaceuticals USA.
Interventions
- DRUG GSK3640254
- DRUG Portia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2019-08-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03984825
The ClinicalTrials.gov registry entry for NCT03984825 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GSK3640254 is the first listed.
NCT03984825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03984825 about?
NCT03984825 is a clinical study titled "Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive". This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodefici...
What is the current status of trial NCT03984825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2019-06-13. Estimated completion is 2019-08-16.
What interventions are being tested in trial NCT03984825?
The interventions under investigation include: GSK3640254 (DRUG), Portia (DRUG).
Who is sponsoring clinical trial NCT03984825?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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